superDimension - Patient Sensor Patch - Covidien LP

Duns Number:058614483

Device Description: Patient Sensor Patch

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More Product Details

Catalog Number

-

Brand Name

superDimension

Version/Model Number

AKI00131-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JAK

Product Code Name

System, x-ray, tomography, computed

Device Record Status

Public Device Record Key

b3644ece-f70f-4c82-add5-e86d221b4754

Public Version Date

September 08, 2022

Public Version Number

2

DI Record Publish Date

November 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40